macitentan and tadalafil

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Generic Name:
macitentan and tadalafil
Project Status:
Complete
Therapeutic Area:
Pulmonary arterial hypertension
Manufacturer:
Janssen Inc.
Brand Name:
Opsynvi
Project Line:
Reimbursement Review
Project Number:
SR0690-000
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to reduce morbidity in patients of WHO functional class (FC) II or III whose PAH is idiopathic, heritable or associated with connective tissue disease or congenital heart disease. OPSYNVI should be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets.
Submission Type:
Initial
Fee Schedule:
Schedule C
Indications:
For the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to reduce morbidity in patients of WHO functional class (FC) II or III whose PAH is idiopathic, heritable or associated with connective tissue disease or congenital heart disease. OPSYNVI should be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient/clinician input open22-Apr-21
Call for patient/clinician input closed11-Jun-21
Clarification:

- No patient input submission received

Submission received20-May-21
Submission accepted04-Jun-21
Review initiated07-Jun-21
Draft CADTH review report(s) provided to sponsor for comment09-Sep-21
Deadline for sponsors comments20-Sep-21
CADTH responses on draft review report(s) provided to sponsor15-Oct-21
Expert committee meeting (initial)27-Oct-21
Draft recommendation issued to sponsor08-Nov-21
Draft recommendation posted for stakeholder feedback18-Nov-21
End of feedback period02-Dec-21
Final recommendation issued to sponsor and drug plans14-Dec-21
Final recommendation posted07-Jan-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)05-Jan-22
CADTH review report(s) posted18-Feb-22